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Diet and Exercise Program for Lymphoma Survivors (LIFE-L Trial)
N/A
Recruiting
Led By Tracy E Crane, Phd, RDN
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
LIFE-L Trial Summary
This trial will study if diet and exercise can help cancer patients complete their treatment and reduce side effects.
Who is the study for?
This trial is for adults over 18 with untreated Non-Hodgkin or Hodgkin lymphoma, starting chemotherapy. Participants must understand English or Spanish, have internet access, and be willing to try a Mediterranean diet and exercise program. They can't already be very active or on special diets like vegan or ketogenic.Check my eligibility
What is being tested?
The study tests if a Mediterranean diet combined with a home-based exercise program helps Lymphoma patients handle chemo better and reduce side effects. Patients will either start this lifestyle intervention immediately or be placed in a waitlist group to compare outcomes.See study design
What are the potential side effects?
Since the interventions are non-medical (diet and exercise), significant side effects are not expected. However, participants may experience mild discomfort as they adjust to new dietary habits and physical activity routines.
LIFE-L Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in percentage of participant satisfaction
Percentage of Participants Completing Intervention Sessions
Percentage of Survivors who participate
Secondary outcome measures
Average Relative Dose Intensity (RDI)
LIFE-L Trial Design
2Treatment groups
Experimental Treatment
Group I: LIFE-L GroupExperimental Treatment3 Interventions
Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.
Group II: Control GroupExperimental Treatment1 Intervention
Participants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention.
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Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,956 Total Patients Enrolled
Tracy E Crane, Phd, RDNPrincipal InvestigatorUniversity of Miami
Craig Moskowitz, MDPrincipal InvestigatorUniversity of Miami
12 Previous Clinical Trials
413 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke, heart attack, or heart failure in the last year.I am under 18 years old.I am unable to give my consent.I am 18 years old or older.I am receiving my chemotherapy at an approved institution.I cannot read or understand English or Spanish.I am willing to follow a Mediterranean diet and exercise plan or be on a waitlist.I have lymphoma that hasn't been treated yet and needs 6 rounds of chemotherapy.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: LIFE-L Group
- Group 2: Control Group
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings in this clinical trial for participants?
"According to clinicaltrials.gov, this medical experiment is not currently enlisting participants. It was first listed on May 31st 2023 and last updated April 19th 2023. Although it's no longer open to applicants, 1,740 other studies have vacancies at present."
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